NCT06928792

Brief Summary

The aim of this research is to check the effects of Quadratus Lumborum (QL) release on respiratory function and pain levels in individuals with chronic low back pain. Randomized controlled trials done at Pakistan Railway General Hospital, Rawalpindi and Rawal General \& Dental Hospital Islamabad. The sample size was 36. The subjects were divided into two groups, 18 subjects in the experimental group will receive muscle energy technique on quadratus lumborum along with conventional intervention for LBP and 18 in control group will only receive conventional intervention exercises for LBP. Study duration was of 6 months. Sampling technique applied was non probability connivance sampling technique. Only 30-60 years both males and females diagnosed with mechanical low back pain persist at least \>3 months. Tools used in the study of Numeric Pain rating scale (Pain assessment). Modified Oswestry Disability Index (m-ODI) (for ADLs in CLBP). Inclinometer (for ranges of lumber spine). Digital spirometer (for FEV1/FVC ratio). Inches Tap (For Chest Expansion) \& (For Quadratus lumborum length test). Fatigue Severity Scale (FSS).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

February 20, 2025

Last Update Submit

April 7, 2025

Conditions

Keywords

Respiratory function testNumeric Pain rating scaleMETsChronic pain

Outcome Measures

Primary Outcomes (4)

  • Numeric Pain rating scale.

    It is the tool to measure pain intensity It ranges from 0 to 10. If the patient feels no pain, then 0 will be marked. 5 shows moderate pain and 10 will be marked if pain is most extreme ever felt by the patient.(10) The patients were asked to mark the point they felt their pain accordingly

    baseline measurement to 2 weeks

  • Digital spirometer.

    Spirometry is a vital pulmonary function test used to assess lung health by measuring Peak Expiratory Flow (PEF)

    baseline measurement to 2 weeks

  • Inches Tap (For Chest Expansion)

    Chest expansion was measured in a standing position with elbows slightly flexed and hands on hips, using a non-stretchable inch tape at the 2nd intercostal space (ICS), 4th ICS, and xiphoid process. Participants performed maximal deep inspiration and expiration, and the difference was recorded.

    baseline measurement to 2 weeks after every session.

  • Fatigue Severity Scale (FSS)

    Unidimensional, nine-item self-reported questionnaire designed to assess the severity and impact of fatigue on daily functioning and quality of life over the past week. Participants rate each item on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree), with higher scores indicating greater fatigue severity. The total score is calculated by summing the individual item scores, resulting in a range from 9 to 63, with a score of ≥36 indicating significant fatigue.

    baseline measurement to 2 weeks.

Secondary Outcomes (6)

  • Inclinometer for Lumbar Flexion.

    baseline measurement to 2 weeks after every session

  • Inclinometer for Lumbar Extension.

    baseline measurement to 2 weeks after every session

  • Inclinometer for Lumbar Side Bending (Rt)

    baseline measurement to 2 weeks after every session

  • Inclinometer for Lumbar Side Bending (Lt)

    baseline measurement to 2 weeks after every session

  • Inclinometer for Lumbar Rotation (Rt)

    baseline measurement to 2 weeks after every session

  • +1 more secondary outcomes

Study Arms (2)

Experimental: interventional group A: Muscle Energy Technique (MET)

EXPERIMENTAL

10 min hot pack application, followed by MET on the Quadratus Lumborum (3 reps with a 7s hold). Flexibility exercises include William flexion with b/L knee-to-chest stretches (10s hold, repeated 10 times) and static stretching of the hamstrings, gastrocnemius, and IT band (5 reps, 5s hold). Strengthening exercises comprise isometric hip flexor activation (5 reps with a 15s hold), side planks (3 reps, 30s hold), and static side bending (5 reps, 10s hold). The intervention will be performed once daily, consisting of 3 sets per session, continued for 4 weeks to enhance flexibility, core stability, and muscular balance, ultimately contributing to pain relief and improved functional mobility in CLBP patients

Other: Experimental interventional group A, (MET).

Control :interventional group B: (conventional intervention exercises)

ACTIVE COMPARATOR

10-minute hot pack application, followed by William flexion with bilateral knee-to-chest stretches (10s hold, reps 10 times). Flexibility exercises consist of static stretching for the hamstrings, gastrocnemius, and iliotibial band (5 reps with a 5s hold). Strengthening exercises include isometric hip flexor activation (5 reps with a 15s hold), side planks (3 reps with a 30s hold), and static side bending (5 reps with a 10s hold). The protocol will be performed once daily, with 3 sets per session, continued for 4 weeks to improve flexibility, core stability, and pain management in CLBP patients.

Other: Control: group B (conventional intervention exercises)

Interventions

10-minute hot pack application, followed by MET on the Quadratus Lumborum (3 repetitions with a 7-second hold). Flexibility exercises include William flexion with bilateral knee-to-chest stretches (10-second hold, repeated 10 times) and static stretching of the hamstrings, gastrocnemius, and iliotibial band (5 repetitions with a 5-second hold). Strengthening exercises comprise isometric hip flexor activation (5 repetitions with a 15-second hold), side planks (3 repetitions with a 30-second hold), and static side bending (5 repetitions with a 10-second hold). The intervention will be performed once daily, consisting of 3 sets per session, continued for 4 weeks to enhance flexibility, core stability, and muscular balance, ultimately contributing to pain relief and improved functional mobility in CLBP patients

Experimental: interventional group A: Muscle Energy Technique (MET)

10-minute hot pack application, followed by William flexion with bilateral knee-to-chest stretches (10-second hold, repeated 10 times). Flexibility exercises consist of static stretching for the hamstrings, gastrocnemius, and iliotibial band (5 repetitions with a 5-second hold). Strengthening exercises include isometric hip flexor activation (5 repetitions with a 15-second hold), side planks (3 repetitions with a 30-second hold), and static side bending (5 repetitions with a 10-second hold). The protocol will be performed once daily, with 3 sets per session, continued for 4 weeks to improve flexibility, core stability, and pain management in CLBP patients.

Control :interventional group B: (conventional intervention exercises)

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 30-60 years.
  • Both Genders: Male and Female.
  • Diagnosed with mechanical low back pain persist at least \>3 months.
  • Self-evaluation of the breathing questionnaire, SEBQ \>11.
  • The patient exhibits decreased pulmonary functional volumes compared to the normal values, which include FEV, FVC,FEV₁/FVC
  • The Quadratus Lumborum length test in side-lying inches indicates QL shortening.
  • Patient with either unilateral or bilateral Quadratus lumborum tightness but intervention will be given on both sides.
  • Numeric Pain Rating \> 3/10.

You may not qualify if:

  • Diagnosed chronic respiratory disease (e.g., asthma, COPD, bronchitis).
  • Diagnosed non-mechanical low back pain (e.g., ankylosing spondylitis, tumors).
  • Diagnosed lumbar spine surgery within the last 12 months.
  • Diagnosed significant neurological deficits.
  • Spinal injuries or other comorbidities.
  • Infection, trauma, pregnancy, fracture, or fall.
  • Unable to understand and follow the commands.
  • Unwillingness to comply with the follow-up schedule.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rawal Institute of Rehabilitation Sciences

Islamabad, Punjab Province, 45550, Pakistan

Location

MeSH Terms

Conditions

Low Back PainChronic Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aisha Razzaq, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The researchers who evaluated the participants were not informed of how the participants were grouped. Participants were informed that they would receive one of two different interventions without indicating which group should undergo METs on Quadratus lumborum or Conventional treatment for chronic low back pain.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to the experimental group or control group after a baseline assessment with a lottery ticket and an opaque envelope containing the same number of folded papers labeled "control" or "intervention." Each participant took a piece of paper that identified their group and gave it to the researchers without seeing what was written. Participants were not notified which group was assigned.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

April 15, 2025

Study Start

January 7, 2025

Primary Completion

December 30, 2025

Study Completion

January 31, 2026

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations